MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR PROSTHESIS

Catalog Number	AMC3022
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the device for evaluation since the device has been implanted in the patient.The physical incubation test (which measures how well the collagen was impregnated into the graft), blood and water permeability previously performed on a different portion of the graft from the same lot number was found to be acceptable.Also, the sister graft which is the another half of the same exact graft had also been implanted successfully and without any reported issues.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.We have sold all of the grafts that were manufactured under this lot number.We have not received any other complaints of a similar nature for devices from this lot.Patient has been discharged from the hospital.However, patient is scheduled for follow-up to be examined for any blood clot formation.Protamine sulphate was used to reverse the effects of the heparin.Due to the excessive bleeding, 3 blood transfusions were required to replenish the lost blood.Physician had to use copious amount of glue to reduce the leak.
Event or Problem Description
During abdominal aneurysm repair, after the anastomosis was performed distally and the aortic clamp was removed, the blood leaked through the entire length of the graft.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7519388
• Report Number: 1220948-2018-00032
• Device Sequence Number: 13812521
• Product Code: MAL
• UDI-Device Identifier: 00840663103492
• UDI-Public: 00840663103492
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: AMC3022
• Device Lot Number: 99104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention